Uromedica seeks light at the end of a (very long) FDA tunnel

Dr. Jeffrey Shuren, director, Center for Devices and Radiological Health, Food and Drug Administration

If the Food and Drug Administration has been too cozy with medical device companies in recent years, as some critics charge, Uromedica Inc. must have missed the memo.

Since 2000, the Plymouth, Minn.-based company has been haggling with the FDA over its balloon device to treat urinary incontinence. Ten years and several clinical studies later, Uromedica is still waiting for FDA approval though the company is already selling the device in Europe. In November, the agency said it could not yet OK Uromedica’s Pre-Market Approval application, which it filed in August 2008.

So last week, Uromedica formally appealed the FDA’s decision to Dr. Jeffrey Shuren, the new director of the agency’s Center for Devices and Radiological Health (CDHR). Uromedica is the medical device industry’s first appeal heard by Dr. Shuren, who assumed the job in January.


The company,  however, isn’t holding its breath. The man Dr. Shuren replaced, Dr. Daniel Schultz, resigned last summer amid criticism that the FDA approved medical devices over the objections of its staff scientists. Schultz has long been a lightening rod for consumer advocacy groups like Public Citizen and the National Research Center for Women and Families.

For example,the Star Tribune in Minneapolis reported in 2008 that he encouraged Acorn Cardiovascular Inc. of New Brighton, Minn. even though an FDA advisory panel recommended the agency deny its PMA application for its cardiac support device. A subsequent FDA dispute resolution panel also declined to approve the device. But with Schultz’s help, Acorn eventually reached an agreement with the FDA for another clinical study, the paper reported.

However, Acorn president Steve Anderson denies Schultz acted out of the ordinary.

“As CDRH Director, Dan was required to work with the two panels to define a clinical study which met the data requests of the panels,” Anderson wrote in an e-mail to MedCity News. “This study would then have to be conducted and, if successful, Acorn would have had to go through a full PMA review process with the FDA with no guarantees whatsoever on success.  The idea that this process meant that Dan was supporting Acorn is completely false and shows a lack of understanding of the process.”

In early 2009, nine staff whistle-blowers wrote to the Obama administration and Congress, accusing the FDA of improperly approving devices despite serious safety concerns. The letter prompted Congressional investigations and calls to toughen the FDA’s  PMA and 510(k) approval programs.

So it’s probably safe to say Uromedica still has a tough road to climb. Already, a former FDA scientist is accusing Shuren and the agency of retaliating against him after he raised concerns about how a CT scanner might expose patients to harmful radiation.

“Given this whistle-blower environment, I doubt Dr. Shuren will overrule his staff,” said Mark DuVal, a Minneapolis-based lawyer representing Uromedica.

Still, DuVal hopes Dr. Shuren will refer the case to an advisory panel, a decision that might come over the next three to four weeks. If not, Uromedica and the FDA will resume their regulatory dance. But given the length of time and the lack of investor cash, one has to wonder if Uromedica will ever win over an agency beset by scrutiny and doubt.

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